Libido pill’s risks have insurers weighing whether to cover it

'Evidence of value'

"I think it's a mistake for any third-party payer to pay for a medication that doesn't come with a reasonably solid evidence of value," said David Juurlink, a physician and professor at the University of Toronto who studies drug safety. "The data for flibanserin make it very clear that the majority of women who take it are not going to experience any meaningful benefit."

The FDA is requiring doctors to get certified through an online training program to be able to prescribe Addyi, and patients will have to sign a form saying they understand the risks.

Sprout plans to make clear to doctors that only some women will benefit from the drug, Whitehead said Wednesday on a conference call with reporters.

"Addyi is not going to work for all women," she said."We're going to set expectations in the marketplace."

Skeptical on alcohol

While Addyi's label warns about the importance of abstaining from alcohol, some women's health experts have been skeptical that patients would take caution.

"In real life, women are not going to be compliant like they are in clinical trials," Vanessa Barnabei, chair of the obstetrics and gynecology department at the State University of New York at Buffalo, said in a phone interview. "They're going to say, 'I feel OK. I'm going to have a drink.' And boom, they go down."

Barnabei said she doesn't think doctors will race to get certified to prescribe Addyi because of the time involved in watching a video online and answering questions as well as counseling patients to ensure they need the drug and are aware of the ri

"My guess is that women are going to have to work hard to find providers that are willing to do this," she said.

—With assistance from Robert Langreth in New York.